Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Salmonella typhimurium strains. Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is AMES assay was performed in Salmonella typhimurium strains TAI535 and TAI538 by usingStandard plate incorporation assay. The test chemical was used at the concentration of 0.1µl/plate in the presence and absence of S9 mix. No mutagenic effects were observed. Therefore Hydroxylamine-O-sulfonic acid was considered to be non mutagenic in Salmonella typhimurium strains TAI535 and TAI538 with and without metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
To evaluate the mutagenic potential of Hydroxylamine-O-sulfonic acid in Salmonella typhimurium strains TAI535 and TAI538 by using Standard plate incorporation assay
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
- Name of test material (IUPAC name): Hydroxylamine-O-sulphonic acid
- Molecular formula: H3NO4S
- Molecular weight: 113.093 g/mol
- Smiles notation: O=S(=O)(ON)O
- InChl: 1S/H3NO4S/c1-5-6(2,3)4/h1H2,(H,2,3,4)
- Substance type: Organic
- Physical state: Solid
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium, other: TAI535 and TAI538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix - liver homogenates(S-9) (9000 g supernatant) from rats induced with a polychlorinated biphenyI (PCB) mixture (Aroclor 1254)
Test concentrations with justification for top dose:
0.1µl
Vehicle / solvent:
Not specified
Untreated negative controls:
yes
Remarks:
Water
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Standard plate incorporation assay
DURATION
- Exposure duration: 48 hour
Rationale for test conditions:
Not specified
Evaluation criteria:
Numbers of Histidine revertants per plates were observed.
Statistics:
Yes, Mean was observed
Key result
Species / strain:
S. typhimurium, other: TAI535 and TAI538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effect were observed

 

Agent

Amount

Revertants per plate

 

 

 

TA1535

TA1538

Test chemical

Hydroxylamine-o-sulfonic acid (HOMS)  

0.1µl

44

16

Positive control

Methyl methanesulfonate

10 µl

439

30

 Negative Control

water

10 µl

13

10

Conclusions:
Hydroxylamine-O-sulfonic acid was evaluated for its mutagenic potential in Salmonella typhimurium strains TAI535 and TAI538 by using Standard plate incorporation assay. The test result was considered to be negative in the presence and absence of S9.
Executive summary:

Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is AMES assay was performed in Salmonella typhimurium strains TAI535 and TAI538 by usingStandard plate incorporation assay. The test chemical was used at the concentration of 0.1µl/plate in the presence and absence of S9 mix. No mutagenic effects were observed. Therefore Hydroxylamine-O-sulfonic acid was considered to be non mutagenic in Salmonella typhimurium strains TAI535 and TAI538 with and without metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Genotoxicity In-vitro;

Various publications and prediction were reviewed to determine the mutagenic nature of  Hydroxylamine-O-sulphonic acid (2950-43-8). The studies are as mentioned below:

Gene mutation toxicity study was performed by HERBERT S. ROSENKRANZ et al. (Mutation Research, 1976) to determine the mutagenic nature of Hydroxylamine-O-sulphonic acid (2950-43-8 )using Salmonella typhimurium strains. Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is AMES assay was performed in Salmonella typhimurium strains TAI535 and TAI538 by usingStandard plate incorporation assay. The test chemical was used at the concentration of 0.1µl/plate in the presence and absence of S9 mix. No mutagenic effects were observed. Therefore Hydroxylamine-O-sulfonic acid was considered to be non mutagenic in Salmonella typhimurium strains TAI535 and TAI538 with and without metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.

 

Supported by a experimental study W.H. Kaluset al. (Chemosphere, 1987 ) to determine the mutagenic nature of-O-sulphonic acid (2950-43-8 using Salmonella typhimurium strains. Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is AMES assay was performed in Salmonella typhimurium strains his G 46, TA 98 and TA 100 by using standard plate-incorporation test. The test chemical was used at the concentration of 0,0.01,0.1,1,2,5 and 10 mg/plate in the presence and absence of S9 mix. A weak, but reproducible mutagenic activity in his G 46was observed .Test chemical was only mutagenic in the excision-repair proficient strain his G 46, but failed to induce mutations in the excision repair deficient strain TA I00. At a concentration of 5 mg/plate hydroxylamine- O-sulfonic acid inhibited growth of his G 46 and TA 100. As only with microsomal activation a mutagenic response was seen assaying Hydroxylamine-O-sulfonic acid the data without S9-mix are not shown. Also the results obtained with TA 98 were omitted because the tested compounds failed to show a mutagenic response in this strain.The test result was considered to be negative for TA 100 while test result was considered to be positive for his G 46 in the presence of S9. As the available data is not sufficient for classification. Hence the test substance cannot be classified.

Another supporting study by HERBERT S. ROSENKRANZet al.( Chemico-Biological Interactions,1973) to determine the mutagenic nature of-O-sulphonic acid (2950-43-8 using Escherichia coli .Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is the growth of DNA polymerase deficient cells was performed in Escherichia coli W3110 (pal A+) and p3478 (pol A-). The test chemical was used at the concentration of 0.14 µmoles in medium HA supplemented with 5 µg thymine per m114g15, were spread onto the surface of Petri plates containing 25 ml of 1.5% agar dissolved in the same medium. When the surface of the agar had dried, paper discs (6.35 mm in diameter) impregnated with the substance to be tested were deposited at the center of the plates. The plates were incubated at 37Cin the dark for 14 h whereupon the diameters of the zones of inhibition were determined. Each substance was tested in replicate on several occasions. Diameter of zone of inhibition (mm) of target substance was compare with positive and negative control diameters of the zones of inhibition. The test result was considered to be positive in Escherichia coli W3110 (pol A+) and p3478 (pol A-)

It is further supported by study conducted by HERBERT S. ROSENKRANZ et al. (Mutation Research, 1976) to determine the mutagenic nature of Hydroxylamine-O-sulphonic acid (2950-43-8) by using Escherichia coli strain. Genetic toxicity in vitro study of Hydroxylamine-O-sulfonic acid was assessed for its possible mutagenic potential. For this purpose is the growth of DNA polymerase deficient cells was performed in Escherichia coli (pal A+) and (pol A-). The test chemical was used at the concentration of 0.1 µl in the presence and absence of S9.The Diameter of zone of inhibition (mm) of target substance was compare with positive and negative control diameters of the zones of inhibition. The test result was considered to be positive in Escherichia coli (pal A+) and (pol A-) for Hydroxylamine-O-sulfonic acid. Therefore the substance was considered to be mutagenic.

As the test chemical Hydroxylamine-O-sulphonic acid (2950-43-8) does not show any mutagenic effect for AMES test. The test result was considered to be negative in salmonella typhimurium strain. Based on that test chemical can be classified as non mutagenic.

Justification for classification or non-classification

As the test chemical Hydroxylamine-O-sulphonic acid (2950-43-8) does not show any mutagenic effect for AMES test. The test result was considered to be negative in salmonella typhimurium strain. Based on that test chemical can be classified as non mutagenic.